thejoe Stradis Healthcare, LLC.

Stradis Healthcare, LLC.: 51 FDA recall reports

Every medical device recall the FDA has published for Stradis Healthcare, LLC.. The fault, and how the agency graded it.

51Reports

0Class I

0Ongoing

2015-07-15Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	51

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Lima Pack - contains Devon Light Glove Used during surgery

Z-2014-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Lima Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 2

Mississippi Pack - contains Devon Light Glove Used during surgery

Z-2008-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Mississippi Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: One

Arthroscopy Pack - contains Devon Light Glove Used during surgery

Z-2041-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Arthroscopy Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 1

Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgery

Z-1997-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 9

Shoulder Pack - contains Devon Light Glove Used during surgery

Z-2025-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Shoulder Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: One

Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove Used during surgery

Z-1996-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 15

Vasc Custom Kit - contains Devon Light Glove Used during surgery

Z-2016-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Vasc Custom Kit - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 3

Skin and Vein Pack - contains Devon Light Glove Used during surgery

Z-2015-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Skin and Vein Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 3

Surgical Pack and General Surgery Pack - contains Devon Light Glove Used during surgery

Z-2007-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Surgical Pack and General Surgery Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 4

Head & Neck Pack - contains Devon Light Glove Used during surgery

Z-2022-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Head & Neck Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 2

Blepharoplasty Pack - contains Devon Light Glove Used during surgery

Z-2037-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Blepharoplasty Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 1

Suction Pack - contains Devon Light Glove Used during surgery

Z-2011-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Suction Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: One

General Pack - contains Devon Light Glove Used during surgery

Z-2002-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: General Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: One

Glaucoma Pack - contains Devon Light Glove Used during surgery

Z-2024-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Glaucoma Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: One

Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used during surgery

Z-2026-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 3

Pediatric Pack - contains Devon Light Glove Used during surgery

Z-2034-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Pediatric Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 1

Custom Pack - contains Devon Light Glove Used during surgery

Z-2038-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Custom Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 1

Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery

Z-2001-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: One

Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove Used during surgery

Z-1999-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 13

Standard Pack - contains Devon Light Glove Used during surgery

Z-1998-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Standard Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: One

Vein & Vascular Pack - contains Devon Light Glove Used during surgery

Z-2003-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Vein & Vascular Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: One

Hand Pack - contains Devon Light Glove Used during surgery

Z-2028-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Hand Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 4

ENT Pack - contains Devon Light Glove Used during surgery

Z-2027-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: ENT Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 2

Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery

Z-2010-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 5

Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery

Z-2000-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: One

Hand Pack - contains Devon Light Glove Used during surgery

Z-2013-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Hand Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 3

Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein Ablation Pack - contains

Z-1995-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein Ablation Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 55

Face Lift Pack - contains Devon Light Glove Used during surgery

Z-2009-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Face Lift Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: One

Podiatry Pack - contains Devon Light Glove Used during surgery

Z-2029-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Podiatry Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 4

Face Neck Pack - contains Devon Light Glove Used during surgery

Z-2018-2015 · Class II · reported 2015-07-15 · Completed

Why it was recalled: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product: Face Neck Pack - contains Devon Light Glove Used during surgery
Where it went: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
How much: 1

Showing the 30 most recent of 51. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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